OSAKA, March 3, 2010--H. Lundbeck A/S (Lundbeck) and Takeda
Pharmaceutical Company Limited (Takeda) today jointly announced the
plans for the additional clinical phase III studies on Lu AA21004
and phase III studies on Lu AA24530 in patients with major
depressive disorder (MDD).

The new programme on Lu AA21004 will consist of four clinical
phase III studies including approximately 2,000 patients with
moderate to severe depression in addition to a long-term extension
study. The planned doses are 10 mg, 15 mg and 20 mg. The pivotal
programme is planned to commence in the first half of 2010.

Following the communication of initial top-line MDD results from
previous phase III studies with Lu AA21004 in June 2009, additional
data from the full programme was received and analysed. These data
showed encouraging results for the potential efficacy and the
tolerability profile of Lu AA21004. Data received towards the end
of 2009 from the clinical phase III programme, with 560 patients in
a MDD trial, showed statistical significance on the primary
efficacy endpoint across all tested doses of Lu AA21004 compared to
placebo in a primarily European-based trial. Also, encouraging
results from an MDD relapse prevention study involving 639 patients
showed statistically significant results on maintenance of efficacy
in long-term treatment of MDD.

"With the full review of all data and dosages available we have
strong data to continue development of Lu AA21004 including
exploring the potential at higher dosages than previously
studied”, says Executive Vice President Anders Gersel
Pedersen, Head of Drug Development at Lundbeck. "We are pleased
that with our partner Takeda we are ready to move forward."

In the completed clinical phase II dose finding study, Lu
AA24530 produced consistent statistically significant improvements
on the primary efficacy endpoint and on key secondary endpoints for
the treatment of MDD. Based on the observed efficacy and
tolerability in patients following treatment with Lu AA24530, the
clinical phase III program will be initiated. The clinical phase
III program will begin with four individual phase III studies of Lu
AA24530, including a long-term study and a relapse prevention
study. Approximately 2,000 patients are planned to be included
investigating doses at 10 mg and 20 mg. Selected trials will
include an active reference compound. The pivotal program is
planned to commence by the end of 2010 and may also include future
planned phase III studies to further investigate the
compound’s benefit and risk profile.

“Central nervous system conditions represent a core
therapeutic area of interest for Takeda,” said Nancy
Joseph-Ridge, M.D., general manager for Takeda’s
pharmaceutical development division. “Together with Lundbeck,
we are pleased to continue our development activities for Lu
AA21004 and Lu AA24530, further evaluating their potential as a
future treatment option for the millions of patients suffering from
depression.”

About Lu AA21004
Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5 HT1A
receptor agonist and 5-HT transporter inhibitor. A number of
investigations in vivo have demonstrated that Lu AA21004 increases
extracellular monoamine (5-HT, noradrenaline and dopamine) and
acetylcholine levels in specific areas of the brain. All of these
activities are considered to be of clinical relevance and involved
in the mechanism of action of Lu AA21004.
Lu AA21004 has demonstrated a low drug-drug interaction potential.
It is extensively metabolized in the liver and the absorption of Lu
AA21004 is independent of food intake.

About Lu AA24530
In pre-clinical studies, Lu AA24530 has demonstrated activities as
a multi-modal enhancer with reuptake inhibition at monoamine
transporters, and antagonist activity at 5-HT3 and 5-HT2c
receptors. In vivo rat studies have demonstrated that treatment
with Lu AA24530 leads to increases in acetylcholine, noradrenaline,
dopamine and 5-HT levels in brain regions that play a key role in
the regulation of mood.

About depression
Depression is a very common, debilitating illness affecting around
121 million people worldwide according to WHO. Depression is the
leading cause of disability as measured by YLDs (Years of Life
lived with Disability) and the 4th leading contributor to the
global burden of disease as measured by DALYs (Disability adjusted
life years) in 2000. By the year 2020, depression is projected to
reach 2nd place of the ranking of DALYs calculated for all ages,
both sexes.
Depression and its impact on peoples’ lives are frequently
not considered to be serious. The symptoms of depression can be
chronic or recurrent, and impact patients both mentally and
physically, yet it is still under-recognized and undertreated with
less than 25 percent of those affected having access to adequate
treatment for their condition[i].

Symptoms can include feelings of sadness, anxiety, loss of
interest in activities, decreased energy, impaired sleep, impaired
concentration, hopelessness, guilt, persistent physical symptoms
such as pain and digestive disorders, and in more severe cases,
suicidal thoughts and suicide attempts.

Takeda and Lundbeck alliance
In September 2007, H. Lundbeck A/S and Takeda Pharmaceutical
Company Limited formed a strategic alliance for the exclusive
co-development and co-commercialization in the United States and
Japan of several compounds in Lundbeck's pipeline for the treatment
of mood and anxiety disorders. The partnership initially focuses on
co-development and co-commercialization of the two most advanced
compounds in Lundbeck's pipeline for mood and anxiety disorders, Lu
AA21004 and Lu AA24530. Once approved, the companies will
co-promote the products in the United States and Japan.

Financial guidance
Lundbeck will present its financial result for 2009 on 4 March
2010. On the same occasion Lundbeck will present the expectations
for the financial result for 2010.

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improve the quality of
life for people suffering from central nervous system (CNS)
disorders. For this purpose Lundbeck is engaged in the research and
development, production, marketing and sale of pharmaceuticals
across the world, targeted at disorders like depression and
anxiety, schizophrenia, insomnia, Huntington’s,
Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen,
Denmark, and employs today over 5,500 people worldwide. Lundbeck is
one of the world’s leading pharmaceutical companies working
with CNS disorders. In 2008, the company's revenue was DKK 11.3
billion (approximately EUR 1.5 billion or USD 2.2 billion). For
more information, please visit www.lundbeck.com.

About Takeda
Located in Osaka, Japan, Takeda (TSE:4502) is a research-based
global company with its main focus on pharmaceuticals. As the
largest pharmaceutical company in Japan and one of the global
leaders of the industry, Takeda is committed to striving toward
better health for individuals and progress in medicine.